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Medically Supervised Ibogaine With 12-Month Digital Recovery Support for Opioid Use Disorder

ConditionsOpioid Use DisorderOpioid WithdrawalSubstance Use Disorders
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorClive Michelsen

About this trial

IBO-CARE is a single-site Phase 1/2a study evaluating the safety, tolerability, feasibility and preliminary outcomes of medically supervised ibogaine with 12 months of recovery support in adults with moderate-to-severe opioid use disorder. Up to 120 candidates will be screened to enrol 60 adults aged 18-65 into three cohorts of 20. Participants meeting the shared opioid-free and negative naloxone-challenge criteria will be randomised 1:1 to Cohort A or Cohort C. Cohort A receives extended-release naltrexone 380 mg intramuscularly and matching oral placebo. Cohort C receives oral ibogaine hydrochloride and matching intramuscular placebo. Cohort B follows a separate, nonrandomised recent-use ibogaine pathway with matching intramuscular placebo and clinically supervised stabilisation. All cohorts attend three monitored oral-treatment admissions at Months 0, 1 and 2. Repeat ibogaine administrations require individual eligibility and safety release. The planned injection schedule comprises twelve calendar-monthly administrations at Months 0-11, with final follow-up at Month 12. All participants receive equivalent preparation, psychological support, continuing addiction care, monthly clinical review and SENTINEL digital recovery support with a Garmin Venu 4. The acute monitoring model includes continuous telemetry during a 72-hour post-dose window, serial 12-lead ECGs, laboratory monitoring, emergency capability and independent safety oversight. Monitoring is extended when clinically required. Wearable information does not replace clinical cardiac monitoring. SENTINEL combines participant reports, wearable trends and scheduled assessments, with high-risk findings reviewed by qualified clinicians. Cohorts A and C use a double-blind, double-dummy comparison. Cohort B is open to the treating team, with masked outcome assessment where feasible. Treatment guesses are collected because the acute effects of ibogaine may reveal allocation. The study estimates preliminary effects and is not designed to establish confirmatory efficacy. The IND application has not yet been filed. The study remains not yet recruiting. ClinicalTrials.gov registration and assignment of an NCT number do not authorise study conduct. Enrolment and investigational treatment will begin only after the IND is in effect, IRB approval is in place, and all applicable DEA, Colorado, investigational-product, clinical-site and digital-system requirements have been satisfied. The registration will be updated when the actual FDA filing details are available.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult aged 18 to 65 years, inclusive.

Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision criteria for moderate or severe opioid use disorder, confirmed by a structured diagnostic assessment conducted by a qualified clinician.

Has current physiological opioid dependence, current non-prescribed use, current opioid agonist treatment requiring an approved transition, or a documented recent history of moderate or severe opioid use disorder followed by supervised withdrawal. Participants entering A/C after at least 30 opioid-free days remain eligible if they otherwise meet the approved criteria. Cohort-specific entry rules govern assignment.

Is voluntarily seeking treatment and has a documented clinical need for an additional treatment option, demonstrated by one or more of the following: Previous unsuccessful evidence-based treatment or medically supervised withdrawal; Relapse following treatment; Difficulty remaining engaged in treatment despite reasonable support; Previous overdose or clinically significant overdose risk; Intolerance of or insufficient response to a standard treatment; An informed and persistent preference to discontinue opioid agonist treatment after available alternatives have been explained.

Disqualifiers

Congenital or acquired long-QT syndrome.

Fridericia-corrected QT interval greater than 450 milliseconds for males or greater than 470 milliseconds for females on a protocol-qualifying screening or pre-dose electrocardiogram, or a stricter threshold required by the FDA-authorised protocol.

History or current evidence of clinically important cardiac disease that could materially increase arrhythmia or haemodynamic risk, including: Torsade de pointes; Ventricular tachycardia or ventricular fibrillation; Previous sudden cardiac arrest; Clinically significant conduction disease; Brugada syndrome; Unexplained cardiac syncope; Cardiomyopathy; Significant heart failure; Significant valvular disease; Active myocarditis or pericarditis; Active or inadequately treated infective endocarditis; Unstable coronary disease; Recent myocardial infarction; Clinically significant atrial or ventricular arrhythmia.

Family history suggesting an inherited arrhythmia syndrome or unexplained premature sudden cardiac death, unless specialist assessment establishes acceptable risk under the protocol.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ibogaine Hydrochloride

    Drug

    Pharmaceutical-quality ibogaine hydrochloride administered orally during monitored admissions at Months 0, 1 and 2 in Cohorts B and C. The formulation, strength, weight-capped dose ceiling, interaction controls, pharmacokinetic schedule, repeat-dose release criteria, residual-noribogaine criteria and stopping rules require approval in the controlled protocol and Investigator's Brochure. Each administration requires a documented eligibility and safety review. Arm Associations: B and C

  • Extended-release naltrexone injection, 380 mg

    Drug

    Extended-release naltrexone 380 mg administered intramuscularly to Cohort A after the approved opioid-free interval, negative naloxone challenge and other clinical eligibility checks. The shared planning schedule is twelve calendar-monthly injections at Months 0-11. Exact timing, first-injection date, subsequent eligibility and missed-dose rules require D5 confirmation. Arm Associations: A

  • Matching Oral Placebo

    Drug

    Matching oral placebo administered during the three monitored admissions at Months 0, 1 and 2 in Cohort A to maintain the double-dummy comparison. Composition, matching, manufacture, accountability and release follow the approved product documentation. Arm Associations: A

  • Matching Intramuscular Placebo

    Drug

    Matching intramuscular placebo administered every four weeks for 12 months.

  • My-E-Health SENTINEL Digital Monitoring and Human-Gated Escalation Platform

    Device

    SENTINEL is a study-provided digital monitoring and clinician-support platform used by all cohorts during baseline monitoring and 12-month follow-up. It combines daily participant reports, Garmin-derived longitudinal wellness data, scheduled psychometric assessments, adherence information, trend visualisation and protocol-defined risk-state classification. Orange, Red and Urgent states route to a named qualified clinician or emergency service under the escalation SOP. SENTINEL does not autonomously diagnose, prescribe, change medication or determine emergency treatment. It does not replace continuous telemetry, clinically interpreted 12-lead ECGs, toxicology, bedside examination or emergency assessment. Remote routines pause during scheduled acute admissions while clinical monitoring continues. Arm Associations: A, B and C

  • Standardized Psychological Preparation, Integration and Recovery Support

    Behavioral

    All cohorts receive standardised psychological preparation, supportive care during monitored admissions, post-treatment integration, weekly online support through Month 3, relapse-prevention planning, overdose-prevention education, continuing-care coordination and monthly face-to-face clinical support through Month 12. Support intensity is equivalent across cohorts. Rescue care, access to evidence-based addiction treatment and individual clinical needs take priority over preserving study allocation. Arm Associations: A, B and C

  • Garmin-Enabled Longitudinal Wellness Monitoring

    Other intervention

    All cohorts receive a Garmin Venu 4 with a study-provided Apple phone, training and connectivity. Protocol-specified wellness information includes sleep, resting heart rate, overnight heart-rate variability, respiration, overnight oxygen-saturation estimates, steps, activity, all-day stress and Body Battery. Data support exploratory longitudinal trends in SENTINEL. The wearable is not used to measure QTc, diagnose arrhythmia or replace telemetry, 12-lead ECGs or clinical assessment. Valid-day and baseline rules and scheduled acute-admission pauses are defined in the data plan. Arm Associations: A, B and C

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Extended-Release Naltrexone With Oral Placebo and SENTINELActive comparator 5 interventions
Group B: Recent-Use Ibogaine With Placebo Injection and SENTINELExperimental treatment 5 interventions
Group C: Randomized Ibogaine With Placebo Injection and SENTINELExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Participants With One or More Treatment-Emergent Serious Adverse Events or Prespecified Adverse Events of Special Interest

Number of participants who experience at least one treatment-emergent serious adverse event or prespecified adverse event of special interest. Prespecified events include death, cardiac arrest, torsade de pointes, ventricular tachycardia or ventricular fibrillation, protocol-defined clinically significant QTcF prolongation, syncope, seizure, aspiration, intensive-care transfer, severe agitation, mania, psychosis, suicide attempt, precipitated withdrawal meeting serious-adverse-event criteria, or overdose. Each participant will be counted once regardless of the number of qualifying events.

Time frame
From first assigned study intervention through 7 days after the third monitored admission, or 7 days after the last actual admission if the treatment course ends early.
2

Maximum Change From the Corresponding Pre-Dose Baseline in Fridericia-Corrected QT Interval

For each monitored admission, change in the Fridericia-corrected QT interval (QTcF) is calculated in milliseconds as each post-dose 12-lead ECG value minus the protocol-defined averaged pre-dose 12-lead ECG baseline for that admission. The outcome is the largest observed QTcF change for each participant across the three admissions. ECGs undergo clinical interpretation. This measure reports QTcF change only; threshold crossings and ventricular arrhythmias are separate outcomes.

Time frame
Pre-dose through 72 hours after each assigned treatment administration at Months 0, 1 and 2.
3

Participants With QTcF of at Least 500 Milliseconds

Number of participants with at least one post-intervention, clinically interpreted 12-lead ECG showing a Fridericia-corrected QT interval (QTcF) of 500 milliseconds or more during any monitored admission. Each participant is counted once regardless of the number of qualifying ECGs. The reported unit is participants.

Time frame
Pre-dose through 72 hours after each assigned treatment administration at Months 0, 1 and 2.
4

Participants With an Increase in QTcF of at Least 60 Milliseconds

Number of participants with at least one post-intervention increase in Fridericia-corrected QT interval (QTcF) of 60 milliseconds or more from the corresponding admission averaged pre-dose 12-lead ECG baseline. ECGs undergo clinical interpretation. Each participant is counted once regardless of the number of qualifying ECGs. The reported unit is participants.

Time frame
Pre-dose through 72 hours after each assigned treatment administration at Months 0, 1 and 2.

Secondary outcomes

1

Area Under the Subjective Opiate Withdrawal Scale Total Score-Time Curve

Area under the total score-time curve from repeated Subjective Opiate Withdrawal Scale (SOWS) assessments, reported in score-hours. The 16 participant-reported items each score from 0 (not at all) to 4 (extremely), giving a total score from 0 to 64. Higher scores indicate more severe withdrawal. Use the same prespecified acute-withdrawal analysis population as for COWS, with results reported separately by cohort.

Time frame
From pre-treatment baseline through 72 hours after the first assigned treatment administration in participants meeting the acute-withdrawal analysis criteria.
2

Change From Baseline in Objective Opiate Withdrawal Scale Total Score

The Objective Opiate Withdrawal Scale (OOWS) is a clinician-rated assessment of 13 observable signs of opioid withdrawal. Each sign is scored 0 if absent and 1 if present. The total score ranges from 0 to 13; higher scores indicate more severe withdrawal. Change is calculated as the total score at each follow-up assessment minus the pre-treatment baseline total score. Negative changes indicate improvement.

Time frame
Pre-treatment baseline; 24, 48 and 72 hours and Day 7 after first assigned treatment; weekly through Month 3 and monthly during Months 4 to 12.
3

Participants Requiring Withdrawal Rescue Treatment

Number of participants requiring protocol-defined withdrawal rescue medication, opioid re-administration or transfer to another withdrawal-management pathway. Rescue use is ascertained from medication-administration and clinical records. Each participant is counted once regardless of the number of rescue interventions. The reported unit is participants; rescue type and reason are recorded separately.

Time frame
From the first assigned treatment administration through 72 hours.
4

Number of Non-Prescribed Opioid-Use Days

Number of days with non-prescribed opioid use, assessed by Timeline Follow-Back and corroborated where possible by toxicology. A day is counted once regardless of the number of use episodes. Results are reported in days for each prespecified recall interval, separately by cohort. Prescribed opioid agonist treatment is distinguished from non-prescribed opioid use.

Time frame
Pre-treatment baseline and monthly assessments through Month 12.

Other outcomes

1

Change From Baseline in Garmin-Derived Total Sleep Duration

Change in Garmin-derived nightly total sleep duration, calculated as the mean for each follow-up month minus the mean over the participant's pre-treatment baseline period. The unit is minutes per night. The outcome quantifies change and is not interpreted as a diagnostic test.

Time frame
Daily during the pre-treatment baseline period and through Month 12; changes summarised separately for Months 1 to 12.
2

Change From Baseline in Garmin Derived Light Sleep Duration

Change in Garmin-derived nightly device-estimated light sleep duration, calculated as the mean for each follow-up month minus the mean over the participant's pre-treatment baseline period. The unit is minutes per night. The outcome quantifies change and is not interpreted as a diagnostic test.

Time frame
Daily during the pre-treatment baseline period and through Month 12; changes summarised separately for Months 1 to 12.
3

Change From Baseline in Garmin Derived Deep Sleep Duration

Change in Garmin-derived nightly device-estimated deep sleep duration, calculated as the mean for each follow-up month minus the mean over the participant's pre-treatment baseline period. The unit is minutes per night. The outcome quantifies change and is not interpreted as a diagnostic test.

Time frame
Daily during the pre-treatment baseline period and through Month 12; changes summarised separately for Months 1 to 12.
4

Change From Baseline in Garmin Derived Rapid Eye Movement Sleep Duration

Change in Garmin-derived nightly device-estimated rapid eye movement sleep duration, calculated as the mean for each follow-up month minus the mean over the participant's pre-treatment baseline period. The unit is minutes per night. The outcome quantifies change and is not interpreted as a diagnostic test.

Time frame
Daily during the pre-treatment baseline period and through Month 12; changes summarised separately for Months 1 to 12.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clive Michelsen

Lead sponsor

My-E-Health UK LImited

Sponsor institution

Source ClinicalTrials.gov

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